SafeDispense - White

Basic Information

• Brand Name: SafeDispense - White
• Primary DI: 00014081222367
• Version / Model: 22236
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-30
• Public Version: 1
• Public Version Date: 2023-04-07
• Public Version Status: New
• Public Device Record Key: f9191e95-30dd-464e-969b-5b7f7eae30c6

Device Description

Floss Holder/dispenser

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JES	FLOSS, DENTAL	Dental	872.6390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64844	Dental floss dispenser	A manual device, similar to a bench tape dispenser, intended to be used to hold and facilitate the cutting of dental floss sections by an operator, typically with minimal contact to prevent cross-contamination; it is intended for use in a clinical setting or in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00014081222367	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]